FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1063772
·
Received June 19, 2008
Report
- Report Number
- 2023826-2008-00844
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 28, 2008
- Report Date
- May 29, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS ONE HAPTIC IS TORN OFF OF THE LENS AND IS MISSING. THERE IS A TEAR IN THE CENTER OF THE OPTIC. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON WAS ADVANCING AN ASPHERIC COLLAMER LENS MODEL CQ2015A IN A COMPETITOR'S CARTRIDGE USING A STAAR INJECTOR AND A LEADING HAPTIC TORE. THERE WAS NO PT CONTACT. THE CARTRIDGE USED WAS NOT A STAAR CARTRIDGE AND IS NOT RECOMMENDED FOR USE IN THE LABELING FOR THIS MODEL LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INJECTOR MODEL: MSI-TM LOT#UNK| CARTRIDGE MODEL: UNK LOT#UNK |